tbuckley/cabot-search huggingface dataset:
Duration of first-line immune checkpoint inhibitor treatment in U.S. patients with melanoma, non–small cell lung cancer, and renal cell carcinoma.
Authors: Alia Rawji, Henry J. Henk, Stacey DaCosta Byfield, Jennifer Malin
Journal: Journal of Clinical Oncology (2022)

411 Background: By 2018, Immune Checkpoint Inhibitor (ICI) drugs had gained FDA approval for the treatment of several cancers including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Recommendations for treatment duration for ICI therapy varies and is often used until either progression of disease or intolerance from toxic effects. Blumenthal et al showed that there is a positive correlation between real-world time to discontinuation (rwTTD) and progression free survival. We report the rwTTD of ICI drug use in first-line of therapy (LOT1) among enrollees diagnosed with melanoma, NSCLC, and RCC between 2015 and 2018, as well as ICI utilization in second-line therapy. Methods: A cohort of patients treated for these 3 cancers between 2015 and 2018 was identified using de-identified data from the Optum Labs Data Warehouse and clinical information from the Optum Cancer Guidance Program’s electronic prior authorization (ePA) platform. De-identified administrative claims data were then linked to ePA information at the patient level to identify details of treatment received and duration of treatment. Eligible patients were enrolled in a commercial or Medicare Advantage (MA) plan and required to initiate treatment within 6 months of diagnosis, enrolled at least 6 months prior to diagnosis date (in order to ensure this was the LOT1) and at least thirty days after start of first identified treatment regimen (in order to identify the full treatment regimen). ICI regimens are defined as those with an ICI drug received within the first 30 days of the LOT1 start date. Duration of ICI use was defined as number of days from LOT1 start to date of last ICI administration in LOT1. We estimate rwTTD accounting for censoring via SAS PROC LIFETEST. Results: In this population, we identified 844 eligible patients with these 3 cancers who received LOT1 ICI therapy from 2015 - 2018. NSCLC is the most common cancer treated with an ICI (N = 598). Median rwTTD varied between 172 and 191 days across these 3 cancers. 68% of melanoma patients remained on LOT1 ICI treatment at 90 days decreasing to 30% at 1 year, while 74% of NSCLC remained on LOT1 ICI for at least 90 days and 40% of RCC patients for 1 year. We observed that of individuals who had an ICI in LOT1, 18% of those with NSCLC moved on to an ICI in LOT2, 39% of those with Melanoma, and 25% of those with RCC. Conclusions: Median rwTTD and the percent of patients remaining on ICI treatment at 90 and 180 days in LOT1 was similar among the three cancers. However, RCC patient are more likely to remain on LOT1 ICI (40%) than those being treated for Melanoma and NSCLC.[Table: see text]
Underrepresented minority clinical trial participation: Perspectives of the research care team and patients.
Authors: Erica T. Warner, Anna C. Revette, Brenda Lormil, Natalie A Booz, Kruti Bhagirath Vora, Jennifer Haas, Beverly Moy
Journal: Journal of Clinical Oncology (2022)

93 Background: Clinical trials (CT) are important treatment options for patients with cancer, yet enrollment rates among underrepresented minority (URM) patients remain suboptimal. Oncology care teams need to assess barriers and facilitators of CT participation and identify practices and resources to better support patients. As part of a larger mixed-methods project, we elicited perspectives on improving URM CT enrollment from oncology research care teams and patients. Methods: We conducted four 60-minute focus groups with 12 oncology physicians, 12 research nurses, and nine clinical research coordinators, and semi-structured interviews with nine URM CT patients at a large academic medical center between January and December 2021. Results: Thematic analysis of the focus groups and interviews identified multiple barriers and potential resources and supports at the patient, healthcare team, institutional, and trial design levels. Barriers included difficulty ensuring patient understanding and informed consent, especially among patients with low health literacy and limited-English proficiency, complex logistical and financial demands of CT participation for patients, and the lack of multidisciplinary oncology care team collaboration. Collectively, these barriers undermined communication, trust, and the quality of patients’ relationships with the care team, all affecting CT participation. Suggested resources and practices included proactive needs assessments for all patients with early engagement of social workers, providing a liaison or navigator for each patient, services and support to reduce patient out of pocket costs, expansion of non-English materials availability and increased used of interpreters, increased training and diversity for all care team roles, and simplifying CT requirements by streamlining informed consent documents, eliminating unnecessary CT-related appointments, and broadening eligibility criteria. Conclusions: Findings suggest that changes in clinical trial design, care team coordination, and early assessment and monitoring of patients’ needs and experiences may help reduce access barriers and increase enrollment of URM patients into cancer CTs.
Real-world outcomes of telehealth initiative to reduce readmissions for patients with cancer.
Authors: Bindiya G Patel, Sarah McCaffrey, Arjun Natarajan, Christopher Emke, Paula Goldberg, Emily Pagel, Alexandria Westerman, Olivia Aranha
Journal: Journal of Clinical Oncology (2022)

387 Background: Unplanned readmissions in patients with cancer increase both financial toxicity and mortality. It adversely impacts their quality of life by increasing distress for the patient and caregivers. Improving the transition from inpatient to outpatient care has shown to reduce readmissions. The goal of our study is to reduce hospital readmission rate for patients with solid malignancies by implementing a Telehealth transitional care visit for patients with a high EPIC readmission score at the time of discharge. Methods: A pilot study of patients with thoracic and gastrointestinal malignancies who had a high (≥23%) EPIC readmission score at discharge home between March 2021 and May 2022 were included. Patients who were discharged to a skilled nursing facility/rehabilitation center and patients who were admitted for scheduled chemotherapy were excluded. Telehealth visit with an Advanced Practice Provider (APP) was scheduled within seven days after discharge. It included evaluation of medications, addressing reasons for the index admission, review of symptoms, concerns and reminders for follow up appointments with the primary oncologist team. Readmission rates were compared to a control cohort. Results: A total of 44 patients with high readmission score underwent a Telehealth visit following discharge home. The median age was 63.5 years (range 38-83). Of the 44 patients, 36% (16) were male and 64% (28) were female. Fourteen (32%) patients had thoracic malignancy and 30 (68%) had gastrointestinal malignancy. All patients had received at least one line of chemotherapy. Twelve of the 44 patients (27.3%) had a true 30-day readmission which was lower compared to the control group (31.8%, 14/44 patients) who did not have a Telehealth intervention. Conclusions: A timely Telehealth visit within seven days of the index admission can positively impact the true 30-day readmission rate for patients with cancer.
Total cost of care of hematologic malignancy episodes versus target price under the Oncology Care Model.
Authors: Jennifer Nguyen, Karen Walsh, Vittorio Maio, Seojin Park, Shivangi Patel, Scott W. Keith, Nathan Handley, Valerie Pracilio Csik
Journal: Journal of Clinical Oncology (2022)

67 Background: In 2016 the Center for Medicare &amp; Medicaid Innovation developed the Oncology Care Model (OCM) in response to increasing cancer-attributable cost for medical services and prescription drugs. Under the OCM, practices are incentivized to provide higher quality and coordinated care through a dual payment model including a Monthly Enhanced Oncology Services (MEOS) payment and potential for performance-based payment (PBP), where PBPs are based on a practice’s total cost of care (TCOC) savings amount relative to a risk-adjusted target amount. On average, hematologic malignancies are burdened with higher costs than other cancer types. The objective of this study was to evaluate whether TCOC and target price were aligned in OCM hematologic malignancy episodes. Methods: This was a retrospective cross-sectional study using OCM claims data from an urban, academic, National Cancer Institute-designated cancer center. The analysis was conducted at the episode level from performance period 1 to 4 (time period: 7/1/2016 to 7/1/2018). A logistic regression with a generalized estimating equation (GEE) was used to assess the likelihood of episode characteristics and TCOC to exceed the target price. A linear regression with a GEE was used to evaluate the mean difference between TCOC and target price episodes. Results: Of the 516 episodes of hematologic malignancies included in the analysis, 55.2% were male and 26.9% were 70-74 years old. 283 episodes (54.8%) exceeded target price. Several parameters were found statistically significantly associated with the likelihood of exceeding and not exceeding target price (Table). Largest positive mean difference from target price was in episodes with Medicare Part D drug use ($24,344) and largest negative difference in radiation use (-$33,758). Conclusions: We found a substantial misalignment between TCOC and target price for hematologic malignancy episodes, with a majority of episodes exceeding target price. This study adds to the existing evidence on the lack of adequate adjustment to the OCM target price. As the OCM concludes, our findings identify areas of opportunity for consideration in future payment models, such as re-evaluating the target price methodology, inclusion of drug costs and adequate adjustment for select parameters (history of chemotherapy, novel therapy, and Part B and D expenditures).[Table: see text]
The treating oncologist as a potential barrier to enrollment in molecular targeted trials.
Authors: Koosha Paydary, Alli DeLuca, Rahul Raj Aggarwal, Lauren Wall, Walter Michael Stadler
Journal: Journal of Clinical Oncology (2022)

407 Background: It has been hypothesized that the rarity of molecular inclusion criteria hampers trial accrual. In this study, we attempted to address this challenge in the context of a SETD2-mutation targeted trial. Methods: Patients who received molecular sequencing services from Tempus were analyzed for the presence of SETD2 molecular variants that matched trial enrollment criteria, and resided within 50 miles from the treatment center or were receiving treatment at clinical sites with strong referral histories. A written notification was issued to the ordering physician whenever a likely match was identified, and additional phone and email outreach follow up, including reasons for not pursuing the clinical trial, was conducted. Results: Over one year, 38 eligible patients were identified, none of which were enrolled. The most common reason for not being enrolled was cohort closure following initial identification and outreach. More specifically, cohort closure occurred &lt; 2 months, 2-4 months, 4-6 months and &gt; 6 months following identification of the mutation in 5, 8, 2 and 7 patients, respectively. Physicians for additional potential patients cited trial consideration as a future option, presence of prohibitive comorbidities, lack of interest, and patient death in 6, 3, 2 and 1 patients, respectively. Physicians for 4 patients did not respond to multiple follow up attempts. In regards to individual follow up, physicians received 0-1, 2-3, and 4 or more follow up outreach notifications regarding trial availability for 14, 19, and 5 patients respectively. Conclusions: Despite identification of a large number of potential trial candidates for a molecular targeted therapeutic trial through use of matching algorithms and extensive treating physician follow up, no patients were enrolled. This raises the hypothesis that the biggest barrier to enrollment, as in other settings, is treating physician motivation and that AI algorithms for identifying potential subjects are insufficient. Larger target populations than anticipated, better coordination between outreach efforts and enrollment status, and directed patient outreach may be necessary.
Bone mineral density testing and the risk of fractures in men initiating androgen-deprivation therapy: Population-based study.
Authors: Jason Hu, Armen G. Aprikian, Alice Dragomir
Journal: Journal of Clinical Oncology (2022)

238 Background: Androgen deprivation therapy (ADT) is a staple of advanced prostate cancer (PCa) treatment, however several side-effects are associated with its long-term use. Notably, loss of bone mineral density (BMD) is accelerated which increases fracture risk. Although guidelines recommend BMD testing when initiating ADT to properly assess baseline fracture risk, there is limited data to support this recommendation in the PCa patient population. The objective was to examine the association between baseline BMD testing (bBMDT) and the risk of fractures in men initiating ADT for PCa. Methods: A retrospective observational cohort study using data from Quebec public healthcare insurance administrative databases was conducted. The cohort included PCa patients who initiated ADT from 2004-2015 and who received at least one year of ADT treatment. Baseline BMD testing was defined as a BMD test performed from 6 months prior to ADT initiation and up to 3 months after. Patients were categorized as either having received bBMDT or not received bBMDT when initiating ADT. The primary study outcomes were incidence of any fracture and incidence of fractures resulting in hospitalization. Inverse probability of treatment weighting was used to adjust for measured baseline characteristics which included patient demographic variables, comorbidities, risk factors for fractures, and use of other medications affecting bone density. Results: We identified 13,532 patients who initiated ADT, of which 2,070 (15.3%) underwent bBMDT. The unadjusted 5-year incidence of any fracture was 15.1% for patients not receiving bBMDT and 14.0% for patients receiving bBMDT. In adjusted analyses, bBMDT (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.76-1.12) was not associated with the risk of any fracture. For fractures requiring hospitalization, bBMDT was associated with a lower risk (HR 0.71, 95%CI 0.52-0.98). Furthermore, bBMDT was associated with increased odds of bisphosphonate use within 1 year of ADT initiation among patients who were bisphosphonate-naïve at baseline (odds ratio [OR] 2.03, 95%CI 1.74-2.36). Conclusions: In our study population, bBMDT was associated with a lower risk of fractures resulting in hospitalization. Given the low uptake of bBMDT, additional efforts emphasizing the importance of BMD testing in guidelines may be needed.
A novel PA-led urgent care model for medical oncology patients at a large academic cancer center.
Authors: Sonal Gandhi, Anthony Chuk Kae Lott, Shirley Bryant, Michelle Whittingham, Cynthia Woodard, Janice Stewart, Helen Mackay, Kim Nguyen
Journal: Journal of Clinical Oncology (2022)

37 Background: Oncology patients are high users of the emergency department (ED), which often results in hospital admissions for management of cancer symptoms or cancer treatment toxicities. Interventions such as urgent care (UC) models can decrease such visits, and help improve patient management, health care utilization, and patient experience. Sunnybrook Health Sciences Centre, a large tertiary care hospital in Toronto, Canada has a high volume of medical oncology ED visits (average 4 per day) with about 50% admitted for management. Methods: A novel physician-assistant (PA) led and physician supervised UC model was developed to assist in medical oncology patient phone triage, assessment, and management of cancer or treatment related issues that would otherwise have been sent to the ED by the oncology team. There were two phases: 1) due to COVID, the patients were managed in a dedicated stream primarily using space and nursing in the ED, 2) a dedicated UC clinic with nursing support was opened for these patients. Results: In phase 1, there were 424 referrals over 24 months; 84% would have otherwise been sent through the usual ED process. 26% of patients were managed with PA navigation outside the UC program in other hospital settings. Of the 204 patients formally treated in the UC stream, 67.7% were discharged home. At 48 hours, 89% of discharged patients were stable or improved; this was 80% at 14 days, and 17.3% came back to the ED or were admitted within 14 days of the UC visit. In phase 2, there have so far been 214 referrals over 5 months; 83.6% would have otherwise been sent to the ED. Of the patients who were assessed, 77.9% were discharged home. Outcomes of these patients are being collected. The top 3 patient issues managed during both phases were: fever, pain, and dyspnea. Fifteen patient telephone surveys were completed, and 93.3% were either satisfied or highly satisfied with their UC experience. Conclusions: A novel PA-led triage and management model for urgent medical oncology patient issues was found in initial phase to be feasible and effective with streamlined care through the ED. Once a dedicated UC clinic was opened, referral volumes increased, and a high rate of ED diversion, patient discharge, and effective care was continued. Patients were also highly satisfied. Several ongoing process and outcome measures are being evaluated to help expand the scope and impact of this resource.
Stakeholder evaluation of a supportive care needs assessment tool for adolescent and young adult (AYA) cancer survivors.
Authors: Kristine L Kwekkeboom, Kitty Montgomery, Jane Evered, Kirsten Norslien, Amanda Marie Parkes, Kat Phelps, Susan Tierney, Cathy Lee-Miller
Journal: Journal of Clinical Oncology (2022)

224 Background: The survivorship needs of Adolescents and Young Adults (AYA) with cancer are complex and differ from other age groups. Evidence suggests that AYA cancer survivors are unaware of and underutilize supportive care services both during and after treatment. Recently, the Needs Assessment &amp; Service Bridge (NA-SB) tool was developed to screen AYAs’ survivorship needs and facilitate delivery of appropriate services. We engaged a stakeholder group of YA cancer survivors from the Midwest United States to provide feedback regarding NA-SB content and administration. Methods: We used a descriptive focus group design. We recruited 10 YA cancer survivors, aged 20-38, of diverse sex, race, rural/urban residence, and on/off active therapy. We held five 90-minute virtual stakeholder group meetings. Before the first meeting, stakeholders reviewed the 57 NA-SB items. The PI and a trained facilitator co-led the meetings, asking participants about the utility of the NA-SB, item content, response options, and administration. Meetings were recorded and transcripts were analyzed deductively, organizing comments by the 9 NA-SB domains. Results: Stakeholders endorsed all original NA-SB items, modified 4 items, and identified 18 new items (Table). Stakeholders recommended that YA patients initially complete the NA-SB in-person shortly after treatment begins, and again electronically at clinical milestones. They suggested using a screening question for each domain, allowing patients to skip items not relevant for them. Conclusions: The stakeholder-engaged process resulted in a modified NA-SB and recommendations for administration that reflect the needs of our Midwestern YA cancer survivor population. Prior to implementation, we will integrate recommendations from clinician experts and align available resources with NA-SB domains.[Table: see text]
Improving the chemotherapy unit by implementing Medication Early Release Project (MERP).
Authors: DR.Mohsen Alzahrani
Journal: Journal of Clinical Oncology (2022)

343 Background: The outpatient oncology infusion suite is a very busy unit and sees an average of 60 to 70 patients per day. A limited number of treatment chairs, one pharmacy hood for biohazardous drug preparation and various other factors have resulted in long waiting times for patients before starting their treatment. To improve the patient experience and to try and alleviate pressure on the preparation pharmacy and nursing services during peak times we investigated the feasibility of an early medication preparation and release program. This would enable rapid admission, assessment and administration of the pre-prepared treatment and in turn have a positive impact on patient flow and equalize the pressure felt by the preparation pharmacy. Methods: In this quality improvement project we formed a committee that met on biweekly basis, this committee included representatives from nursing, quality, pharmacy, data analysis and was led by a consultant physician. We studied the baseline data of patient waiting times from January to March 2019 and factors that caused patient delays in being treated. Patient selection criteria were prepared to identify patients that could safely have their medication released early in the morning at 7 am enabling pharmacy to dispense at 8 am without their actual presence being required in the infusion suite. Multiple PDSA cycles with several process changes and educational interventions were implemented to achieve our goal. Results: Baseline data identified that the average waiting time was 2.27 hrs a with a range of waiting times between 33 minutes to 5.07 hrs. After the first intervention the average waiting time reduced to 1 hr. and 24 minutes through each PDSA cycle we could see small improvements in the average time. The major breakthrough appeared following the intensive patient education program and enforcement of strict compliance with the criteria in selecting patients appropriate for the early release program. team sustained and keep average waiting time within control limit of less than one hour from 8th month of the program until January 2021 to be 33 minutes. We identified drug wastage for patients who did not show up as a balancing measure. We were successful in reducing the drug wastage by applying several changes and patient education measures and reached zero wastages. Patient satisfaction survey were conducted they were satisfied after their enrolment in the program. Conclusions: Positive impact has been seen with a significant reduction in the average waiting time from 2.24 hours to 41 minutes exactly. With further interventions relating to patient education and root cause analysis of any patients who are spending longer than necessary in the waiting area we aim to improve this further, an expansion of the pharmacy's capacity to prepare more than 10â€“15 preparations between 7â€“8 am may give rise to a further expansion of the criteria for patients to be included in the MERP pathway.